Upper Extremity Home Exercises in Patients With Scleroderma

Scleroderma Clinical Trial

Official title:

Investigation of Upper Extremity Home Exercises Effects on Grip Strength, Range of Motion, Activity Performance and Funcionality in Patients With Scleroderma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05080738
• Other study ID #: 2021-085
• Status: Completed
• Phase: N/A
• Start date: September 10, 2021
• Est. completion date: June 15, 2022

Study information

• Verified date: October 2022
• Source: Pamukkale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Hand involvement in scleroderma leads to functional disability due to the relationship between grip strength, wrist and finger movement. The vast majority of patients report that their activities are restricted and their quality of life decreases for this reason. Literature indicate that more work is needed to continue to develop and evaluate rehabilitation interventions in this population.

This study is a randomized controlled study examining the effects of 8 weeks of upper extremity home exercises on grip strength, normal joint movement, activity performance and functionality in patients with scleroderma. In our study, it is aimed to contribute to the standardization of upper extremity exercise protocols for scleroderma patients, to increase the quality of life of patients and to increase their independence in daily living activities.

Description:

The primary aim of the study is to examine the effects of upper extremity exercises on joint range of motion, grip strength, activity performance and functionality in patients with scleroderma, and thus contribute to the standardization of exercise protocols for the upper extremity in patients with scleroderma. The secondary aim of the study is to ensure the independence of scleroderma patients in their daily living activities and to increase their quality of life.

At least 46 scleroderma patients meeting the inclusion criteria will be included in the study. Demographic information form, Canadian Activity Performance Measurement (COPM), Arm, Shoulder and Hand Problems Questionnaire (DASH), Chronic Rheumatological Influence of the Hands Assessment and Measurement Score Questionnaire (SACRAH), Duruöz Hand Index (DHI) will be applied to the patients, upper extremity joint range of motion will be applied, gross and fine grip strength measurements will be made.

After the initial evaluation, patients will be randomized to intervention and control groups. Upper extremity home exercises including stretching and strengthening will be taught to the intervention group, and they will be asked to do it 5 days a week for 8 weeks. For eight weeks, the patients will be supported by the phone by the physiotherapist and it will be checked whether they do the exercises. The control group will be trained on the principles of joint protection. At the end of eight weeks, patients will have their final evaluation and analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: June 15, 2022
• Est. primary completion date: June 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Having a diagnosis of SSc according to 2013 ACR/EULAR criteria

• Having upper extremity/hand involvement

• Voluntary and consent to participate in the study

Exclusion Criteria:

• Having a known diagnosis of additional rheumatological disease

• Diagnosis of any known non-rheumatic disease

• Existence of deformity that prevents doing the exercises

• Presence of active digital ulcer Being involved in another rehabilitation program

• Having cognitive disorder

• Failure to give consent to participate in the study

Related Conditions & MeSH terms

• Scleroderma
• Scleroderma, Diffuse
• Scleroderma, Localized
• Scleroderma, Systemic
• System; Sclerosis

Intervention

Other:
• Upper Extremity Home Exercises
The exercises will be performed as follows: Stretching exercises: It will be applied in the form of 10 seconds*10 repetitions for fingers, wrists, elbows and shoulders. Strengthening exercises: It will be applied as 2 sets*10 repetitions for fingers, wrists, elbows and shoulders.

Locations

Country	Name	City	State
Turkey	Antalya Training and Research Hospital	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Landim SF, Bertolo MB, Marcatto de Abreu MF, Del Rio AP, Mazon CC, Marques-Neto JF, Poole JL, de Paiva Magalhães E. The evaluation of a home-based program for hands in patients with systemic sclerosis. J Hand Ther. 2019 Jul - Sep;32(3):313-321. doi: 10.10 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Activity Performance	Canadian Activity Performance Measure (Canadian Occupational Performance Measure=COPM/COPM): COPM is a standard measurement tool used to identify an individual's activity performance problems and measure performance satisfaction. COPM is administered as a semi-structured interview. The patient is asked to identify, discuss and rank certain activities that cause him or her difficulty. The five most important issues (as chosen by the patient) are recorded and the patient is asked to indicate their perception of how well they are currently performing the task and to rate how satisfied they are with this level of performance on a scale of 1 to 10 (1-5 not able to / not at all satisfied). not staying and being able to do it very well / extremely satisfied). Performance (COPM-P) and satisfaction (COPM-S) scores are summed separately and divided by five (number of problem areas). This gives average performance and satisfaction scores.	8 weeks
Primary	Grip strength	Gross grip strength will be measured with a hand dynamometer (Jamar) 3 times for both hands while the patient is sitting with the elbows bent at 90 degrees near the body and the average will be taken.; Fine grip strength will be measured and recorded with a pinchmeter as lateral, triple and fingertip.	8 weeks
Secondary	Score for Assessment and quantification of Chronic Rheumatic Affections of the Hands=SACRAH	The newly developed questionnaire SACRAH includes 23 VASs covering three symptom categories (function, joint stiffness, pain) that primarily determine the status of patients with rheumatic diseases of the hand. The first part consists of 17 questions evaluating hand function. The determined daily activities are eval	8 weeks
Secondary	Duruöz Hand Index (Duruöz Hand Index=DHI/DEI)	It consists of 18 items evaluating hand and wrist activities. The answers are evaluated on a 6-level (0-5) Likert scale and the total score ranges from 0 to 90. The degree of difficulty of the patients in trying to perform these daily activities without using any assistive devices is scored. If the patient can perform this activity without any difficulty, it is scored 0, 1 if it can be done with little difficulty, 2 if it can be done with a little difficulty, 3 if it is very difficult, 4 if it is almost impossible to perform this activity, and 5 if it is completely impossible. The values given for each activity are summed at the end of the index and this value gives the patient's DHI value.	8 weeks
Secondary	Range of Motion	Flexion and extension range of motion will be measured and recorded by the physiotherapist passively and actively with universal goniometer and finger goniometer at appropriate positions.	8 weeks
Secondary	Disabilities of Arm, Shoulder and Hand questionnaire:	It consists of three parts: The first part consists of 30 questions; 21 questions assess the patient's difficulty during activities of daily living, 5 questions assess symptoms (pain, activity-related pain, tingling, stiffness, weakness), and 4 questions assess social function, work, sleep and self-confidence of the patient. In all questions, the patient marks the appropriate answer according to the 5-point Likert system (1: no difficulty, 2: mild difficulty, 3: moderate difficulty, 4: extreme difficulty, 5: not at all). The scores for each section are summed and divided by the number of questions and '1' is subtracted from the result. The result found is multiplied by 25. Results from 0 to 100 are obtained from each section (0: no disability, 100: maximum disability).	8 weeks